Do you think designating Wegovy and Mounjaro as "medications at risk of misuse and abuse" can prevent misuse and abuse of obesity treatments?
It emerged on the 2nd that the Ministery of Food and Drug Safety is proceeding with procedures to designate obesity treatments such as Wegovy and Mounjaro as "medications at risk of misuse and abuse." After regulatory review and an administrative pre-announcement, the related notice is expected to be revised as early as this month.
If designated as medications at risk of misuse and abuse, related warning phrases must be displayed on product packaging, and they cannot be sold without a doctor's prescription even in areas exempt from the separation of prescribing and dispensing (eup, myeon and island regions where it is difficult to use both medical institutions and pharmacies). They will also be subject to monitoring of prescribing status through the Health Insurance Review & Assessment Service (HIRA)'s Drug Utilization Review (DUR), among others.
The government cites as the basis for pushing the regulation the rise in cosmetic-use prescriptions, illegal online transactions, overseas direct purchases and "shopping trips" abroad amid a weight-loss craze.
On the other hand, some in the medical and industry communities argue the regulation is inappropriate and has limits in effectiveness.
As the market grows rapidly with the advent of obesity treatments that mimic the action of glucagon-like peptide (GLP)-1, a hormone secreted in the gut, debate continues over whether designation as medications at risk of misuse and abuse is the right solution.
◇ "Unbridled use must be curbed"… government to tighten misuse and abuse control
Novo Nordisk's Wegovy and Eli Lilly and Company's Mounjaro were launched in the domestic market in Oct. 2024 and Aug. 2025, respectively. They became so explosively popular that shortages appeared even in the domestic market.
The problem is that controversy has erupted as prescriptions increase not only for obesity patients but also for consumers of normal weight or merely overweight for cosmetic purposes.
The Ministery of Food and Drug Safety considers designation as medications at risk of misuse and abuse to be the minimum safety device to manage these problems.
In fact, social media and online communities are flooded with weight-loss testimonials and prescription information using obesity treatments. So-called "shopping trips" to buy products overseas, including in Japan, are also increasing. Some local pharmacies touting low prices are even called "meccas for obesity treatments."
The Ministery of Food and Drug Safety warns that for medicines distributed overseas, it is difficult to verify manufacturing and distribution channels and the possibility that counterfeit medicines are mixed in cannot be ruled out. A recent inspection of distribution practices for GLP-1 obesity treatments uncovered pharmacies that sold medicines without prescriptions or failed to prepare medical records.
In the industry, the view is that the Ministery of Food and Drug Safety will use the designation as medications at risk of misuse and abuse as grounds to strengthen monitoring of advertising and sales activities, and will also carry out more systematic crackdowns in cooperation with related agencies such as the Korea Customs Service.
◇ "The paradox of regulating only treatments"
However, counterarguments are also mounting in the medical community. The claim is that this measure will reduce effectiveness and could reinforce social stigma toward obesity.
A drug-safety expert formerly at a global big pharma said, "GLP-1 obesity treatments have not shown clinical cases of abuse or an addiction profile," adding, "In the United States and Europe, they are not classified as drugs with abuse risk."
It is difficult to find cases where regulators in the United States, Europe and Japan operate a separate management system like Korea's "medications at risk of misuse and abuse," and the general approach is to focus crackdowns on counterfeit medicines, illegal online sales and distribution of unapproved products.
A private practitioner said, "Only recently has there been a mood to recognize obesity as a disease, and attaching the phrase 'at risk of misuse and abuse' to obesity treatments itself can reinforce social stigma against treatment."
The practitioner said, "Wegovy and Mounjaro are not simple weight-loss pills but treatments that help with blood sugar control, reduction of cardiovascular risk and improvement of metabolic diseases in obesity patients," adding, "If anything, by bringing them under reimbursement and clarifying indications and prescribing criteria, we can alleviate misuse and abuse problems arising in the non-reimbursed market."
Some also note that problems with overseas direct purchases and shopping trips abroad will not be solved by attaching warning phrases to domestic product packaging. They argue that this is a problem of demand structure and that regulating treatments is not appropriate.